Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. ISO 13485:2003 also calls out the standard as the preferred method. In the European Union, EN ISO 14971:2012 is a harmonized standard and notified bodies will expect full compliance. This can be confusing for the uninitiated, but LSTI offers a convenient online solution to get you and your colleagues up to speed with risk management principles for medical devices.
Join our online training course where you will learn:
- An overview of ISO 14971 to place the presentation in context – build your foundation
- FDA requirements for risk analysis as part of design validation – what you must know
- Recognition status of ISO 14971 by the FDA and for the EU MDD
- The GHTF guidance document on risk management principles
- Developing a risk evaluation for your product – implementing strategies for success